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BioWorld - Wednesday, December 10, 2025
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Doctor-patient consultation

J&J pushes to elevate patient voices in Asia

Nov. 13, 2025
By Tamra Sami
No Comments
Up to 77% of patients with non-small-cell lung cancer in Asia-Pacific rely almost entirely on their physicians to decide their treatment, even though 69% of physicians say they encourage shared decision-making. That disconnect remains one of the region’s biggest obstacles to improving outcomes, Anthony Elgamal, vice president of Oncology Asia Pacific at Johnson & Johnson Innovative Medicine, told BioWorld.
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Female doctor and patient
FT Global Pharma and Biotech Summit

Could restricting diversity efforts stall women’s health research?

Nov. 12, 2025
By Nuala Moran
No Comments
Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12.
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Man falling asleep in car

Alkermes’ alixorexton hits endpoints in narcolepsy phase II

Nov. 12, 2025
By Lee Landenberger
No Comments
Alkermes plc’s placebo-controlled phase II study of alixorexton in treating narcolepsy type 2 (NT2) hit its dual primary endpoints, producing statistically significant and clinically meaningful improvement in wakefulness and excessive daytime sleepiness. Alkermes said alixorexton is the first oral orexin 2 receptor agonist that has shown efficacy in a large phase II clinical trial in those with NT2.
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Liver anatomy with virus

Bluejay way: Positive phase II data for treating hepatitis D

Nov. 11, 2025
By Lee Landenberger
No Comments
Bluejay Therapeutics Inc.’s lead compound, the fully human monoclonal antibody brelovitug (BJT-778), produced positive virologic response data in the company’s phase II study of chronic hepatitis D virus, a condition with no approved treatment in the U.S.
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Art concept for bladder

Up the bladder ladder, Engene tweak means phase II bell rung

Nov. 11, 2025
By Randy Osborne
No Comments
Engene Holdings Inc.’s protocol amendment to its phase II trial with detalimogene voraplasmid in bladder cancer worked out in a big way, and shares of the firm closed Nov. 11 at $8.82, up $2.81, or 47%. Engene rolled out additional preliminary data from the pivotal cohort of the ongoing Legend study testing the nonviral gene therapy in high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without concomitant papillary disease.
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Stomach cross-section on scientific background

A second win for Cogent pushes the company toward two NDAs

Nov. 10, 2025
By Lee Landenberger
No Comments
Cogent Biosciences Inc. is now lining up two NDA submissions for its tyrosine kinase inhibitor bezuclastinib in treating two forms of cancer. Cogent intends to submit an NDA for bezuclastinib, a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V, in the first half of 2026 to treat gastrointestinal stromal tumors. That will follow the company’s plans for an NDA submission for bezuclastinib in treating non-advanced systemic mastocytosis before the end of 2025.
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Liver over digital lens background

MASH prospects from Rivus, Metavia show promise in phase II

Nov. 7, 2025
By Karen Carey
No Comments
Phase II data being presented at the American Association for the Study of Liver Diseases annual meeting indicate drug development in the field of metabolic dysfunction-associated steatohepatitis (MASH) is making steady progress.
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Kidneys, pills and chart line

Eledon tego for phase III in transplant despite midstage miss

Nov. 7, 2025
By Randy Osborne
No Comments
A primary endpoint failure but with outstanding estimated glomerular filtration rates and impressive safety data in the phase II trial called Bestow are adding up to plans for later-stage work with Eledon Pharmaceuticals Inc.’s tegoprubart (tego) for preventing rejection in de novo kidney transplant.
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Illustration of antibodies flying around a kidney

Takeda’s mezagitamab shows lasting kidney function in IgA nephropathy

Nov. 7, 2025
By Tamra Sami
No Comments
Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody, mezagitamab (TAK-079), sustained kidney function up to 18 months after treatment ended in patients with primary immunoglobulin A (IgA) nephropathy, showing early signs of disease modification in a phase Ib study presented at the American Society of Nephrology’s Kidney Week 2025 in Houston.
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3D illustration showing presence of tumor inside prostate gland

Advancell sets new radiopharma standard in prostate cancer

Nov. 6, 2025
By Tamra Sami
No Comments
Aussie radiopharma company Advancell Co. Ltd. unveiled promising early clinical data that could redefine how advanced prostate cancer is treated by targeted alpha therapies in the radiopharmaceutical space.
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